by Darin Ellingson, Validation SME, Verista
A recent trip to the grocery store was a mind-blowing experience. I wrote a list and forgot to bring it with me. No worries! My new smart fridge saves the day. I check the app to see a current picture of what’s there. The app also tells me that the bread will expire tomorrow, Oat Milk is running low, and that the water filter needs to be replaced. Wow! A camera, a few sensors, and WiFi in that fridge, plus the app makes that possible. I grab the groceries that I need and stop at the appliance store across the street for a new filter. While this smart fridge seemed like a luxury item, its practicality has more than paid for itself by eliminating multiple trips to the store, thus saving time, money, and fuel.
Where smart technologies in the home are more of a convenience, these items are increasingly being adopted in manufacturing of food, consumer goods, and medicines (pharmaceuticals and biologics). Critical information around manufacturing operations and supply chain are collected and transmitted via sensors, RFID tags, bar codes, smart labels, and electronic systems that aggregate and disseminate data to the appropriate staff. These technologies are referred to as Industry 4.0, and in our case, the ISPE has coined Pharma 4.0 to describe this industrial revolution. The specific technology focus of this article is on the Industrial Internet of Things or IIoT. These smart devices employ IoT sensors and tags in an industrial setting.
Smart technologies sound great, but what are the practical applications of these technologies in the pharma/biotech industry? These are some simple, yet attainable practical usages of IIoT/Pharma 4.0:
- Product Integrity – Bi-Directional communication and product authentication throughout the supply chain via sensors, RFID tags, smart labels that track storage temps, humidity, and other critical parameters. Near Field Communication sensors used to scan drug or vaccine packages to verify authenticity and that cold chain has been maintained.
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Digital Fingerprints – IIoT sensors and tags used throughout the manufacturing process to ensure specifications are met for raw materials, intermediates, formulations, and packaging. This set of data is used as a digital fingerprint (block chain) and enables traceability of materials from receipt at the GMP warehouse all the way through the sales cycle and eventually to dispensing to a patient.
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Smart Warehouse – optimize warehousing based on tags and sensors to provide enhanced visibility into the supply chain. Transmitters within warehouses capture consignment movement of items and report in real-time stock levels, quantities and lots available for use, quarantine status, restock triggers, storage conditions, alarm levels, etc. Sensors and tagging of warehoused items provide real-time views of everything tracked within.
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Predictive Maintenance – utilizing sensors to monitor critical process equipment, particularly those used in manufacturing, provide enhanced insights into maintenance. Classically, preventative maintenance has been the status quo, which prevents equipment from failing by performing maintenance at specific intervals. These down times for maintenance often are disruptive to manufacturing environments, which equates to lost revenue. Preventative maintenance does not consider if the maintenance was warranted. Predictive maintenance can eliminate costly unwarranted down times by collecting KPIs for specific pieces of equipment and provide trending details for data driven decisions on maintenance. If equipment is not trending towards failure, why “fix” it.
Many common challenges with implementing IIoT in pharma and biotech (as well as other Pharma 4.0 technologies) are directly related to common factors. Is your business prepared for major transformations? Cisco reported in 2017 that only 40% of IIoT projects made it past PoC, and that 26% of companies considered their IIoT initiatives were successful. Why would this be the case? Consider the following items as critical to successful IIoT programs:
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Management Support – while the benefits to IIoT are apparent, management still needs to buy in and support efforts that are highly complex and transformative to their business operations.
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Business Model – are your IIoT efforts designed to work with your business model? Are KPI improvements and goals measurable and achievable? Does your business model require updates to support IIoT initiatives?
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Technology – have you assessed your current technology base against what is required to achieve success with IIoT projects? What kind of investments are required? How much investment is required? Can a phased approach be utilized?
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Architecture – does your IT and OT architecture require a redesign to support IIoT? Will your existing systems and equipment interface with IIoT devices? Is your business averse to cloud usage?
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Business Processes – do your current processes require redesign for support of IIoT and related technology? What processes require changes and how is compliance maintained?
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People – are your people prepared for major business transformation? Is your staff appropriately trained to understand and support the transformation and beyond? Is your staff effective in working cross functionally?
Next steps for companies that are enabling Pharma 4.0 within their enterprise is the process of making your data work for you. You are collecting mission critical data in systems across your enterprise but are you using this data for Data Driven Decisions (D3)? Incorporating Advanced Analytics opens the door to D3 and intimate details of business operations from real time dashboards. No more waiting a few hours or days to deliver critical reports to the appropriate people, the data is at your fingertips and provides near and long-term trending plus the ability to adopt of AI/ML Tools for automation of analytics and decision support. Instead of notifying someone to take action, AI/ML can take action for you.
Reach out to Verista to see how we can help you with your next IIoT project!
